Z-3257-2026Class II

Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A...

Name: Z-3257-2026 Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A...
Creator: Baxter Healthcare Corporation
Published: 2026-08-03
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2026-08-03 / Open, Classified

FDA source

Recall record

Recall number: Z-3257-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-03
Posted: 2026-09-23
Recalling firm: Baxter Healthcare Corporation
Product: Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Number: M08594A Software Version: N/A Product Description: VOLARA, HOMECARE, NORTH AMERICA Component: No
Product code: NHJ Device, Positive Pressure Breathing, Intermittent
Reason for recall: Contamination within the release test equipment flow path could have affected the accuracy of the nebulizer flow rate. Affected devices returned to firm and testing confirmed devices meet specifications.
FDA root cause: Device Design
Action: Affected consignees were notified by phone on August 3, 2026. Customers were informed that as a precaution, Baxter would replace impacted VOLARA devices. A Baxter clinical trainer would contact the customers to schedule a home visit to exchange the device. Customers were asked to continue to use the VOLARA device as prescribed until it was exchanged. As of August 13, 2026, all potentially affected devices have been returned to Baxter.
Quantity in commerce: 2
Distribution: US Nationwide distribution in the states of Colorado and Florida.
Product codes and lots: Lot Code: UDI: 00887761981690 Serial Numbers: W078SY3553 and Z309SY7853

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3257-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3257-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-30	2026-09-23

Product code NHJ

K200988Class IIMaximus SystemHill-Rom Services Pte, Ltd. / cleared 2020-05-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-29. View this recall on fda.gov (opens on fda.gov)